Outcome of the public consultation on the review of Regulation (EC) 1234/2008

Outcome of the public consultation on the review of Regulation (EC) 1234/2008  

 A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found below.

• Summary(16 KB)

Total:43 contributions

National authorities (14 contributions):

(1) Belgium FAGG-AFMPS Federal Agency for Medicines and Health Products(13 KB)

(2) Czech Republic Institute for State Control of Veterinary Biologicals and Medicaments (14 KB)

(3) Czech Republic State Institute for Drug Control and Ministry of Health   (174 KB)

(4) Denmark Ministry of Health(59 KB)

(5) France Agence Nationale du Médicament Vétérinaire(906 KB)

(6) Germany BfArM PEI BVL(227 KB)

(7) Hungary Ministry of National Resources(8 KB)

(8) Italy Ministerio della Salute Dipartimento della Sanità Pubblica Veterinaria(38 KB)

(9) Lithuania States Medicines Control Agency(50 KB)

(10) Netherlands Ministry of Economic Affairs, Agriculture and Innovation(16 KB)

(11) Poland The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (172 KB)

(12) Spain AGEMED(111 KB)

(13) UK MHRA(176 KB)

(14) UK Veterinary Medicines Directorate (VMD)(2 MB)

Industry (24 contributions):

Associations (14 contributions)

(15) AESGP – Association of the European Self-Medication Industry(71 KB)

(16) APIC – Active Pharmaceutical Ingredients Committee(34 KB)

(17) APREFAR – Portuguese Regulatory Professionals Association(8 KB)

(18) BPI – German Pharmaceutical Industry Association(94 KB)

(19) EAEPC –  European Association of Euro-Pharmaceutical Companies(956 KB)

(20) ECHAMP(61 KB)

(21) EFPIA – European Federation of Pharmaceutical Industries and Associations, including:(164 KB)

–      EBE - European Biopharmaceutical Enterprises

–      EVM - European Vaccines Manufacturers Association

(22) EGA – European Generic Medicines Association(151 KB)

(23) EGGVP – European Group for Generic Veterinary Products(154 KB)

(24) EUCOPE  –  European Confederation of Pharmaceutical Entrepreneurs(794 KB)

(25) EUROPABIO – European Association for Bioindustries(128 KB)

(26) EVM– European Vaccines Manufacturers Association(25 KB)

(27) IFAH-Europe – International Federation for Animal Health – Europe(90 KB)

(28) IPFA  –  International Plasma Fractionation Association(99 KB)

Individual companies (10  contributions)

(29) Apotex Europe BV(72 KB)

(30) Bimeda(157 KB)

(31) ELC GROUP(26 KB)

(32) Laboratoire du Fractionnement et des Biotechnologies (LFB, S.A.).(157 KB)

(33) Laboratorios Maymó, S.A.(184 KB)

(34) MSD(64 KB)

(35) Mundipharma Research Ltd.(238 KB)

(36) Sanofi-Aventis GmbH Österreich(52 KB)

(37) Stallergenes(209 KB)

(38) Weleda AG(9 KB)

Other stakeholders (5 contributions):

(39) CMD(h) – Coordination Group for Mutual Recognition and Decentralised Procedures (human)  (192 KB)

(40) CMD(v) – Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary)  (4 MB)

(41) EMA(183 KB)

(42) Nilesh Sheth(17 KB)

(43)Prescrire (405 KB)

 

•  Better Regulation - Major developments